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NCT03593759 · ClinicalTrials.gov registry record · Phase 3

Cardiac Sarcoidosis Randomized Trial

A Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis, sponsored by Ottawa Heart Institute Research Corporation.

Recruiting
Registry status
Phase 3
Development phase
194
Enrollment target
20
Study locations

NCT03593759 is a Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis that is actively recruiting participants, run by Ottawa Heart Institute Research Corporation. The registered enrollment target is 194 participants, below the 2,160-participant average among 21 other Sarcoidosis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT03593759, a Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis, is actively recruiting participants, sponsored by Ottawa Heart Institute Research Corporation.

RECRUITING
Registry status
Phase 3
Development phase
194 participants
Enrollment target
20
Study locations

Study Summary

Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

Interventions

  • DRUG Methotrexate
  • DRUG Prednisone or Prednisolone

Study Locations (20)

Quebec

  • Montreal Heart Institute - Montreal
  • CIUSSS-Hopital du Sacre-Coeur de Montreal - Montreal
  • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval - Québec
  • CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont - Sherbrooke

Ontario

  • St. Joseph's Healthcare Centre - Hamilton
  • London Health Sciences Centre - London
  • University of Ottawa Heart Institute - Ottawa

Connecticut

  • Yale-New Haven Hospital - New Haven

Massachusetts

  • Tufts Medical Center - Boston

Michigan

  • University of Michigan-Michigan Medicine Cardiovascular Center - Ann Arbor

Minnesota

  • University of Minnesota - Minneota

New York

  • Montefiore Medical Center - New York

Ohio

  • The Ohio State University Wexner Medical Center - Columbus

Trial Details

FieldValue
Enrollment Target 194 participants
Start Date 2019-01-15
Est. Completion 2025-12
Phase Phase 3

What the Registry Record Tells You About NCT03593759

The ClinicalTrials.gov registry entry for NCT03593759 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,160-participant average among 21 other Sarcoidosis trials with a reported enrollment target (91% lower). The listed sponsor is Ottawa Heart Institute Research Corporation, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sarcoidosis appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate is the first listed.

NCT03593759 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Quebec, Ontario, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03593759 about?

NCT03593759 is a clinical study titled "Cardiac Sarcoidosis Randomized Trial". Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low do...

What is the current status of trial NCT03593759?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2019-01-15. Estimated completion is 2025-12.

What conditions does trial NCT03593759 study?

This clinical trial studies the following conditions: Sarcoidosis, Cardiac Sarcoidosis.

What interventions are being tested in trial NCT03593759?

The interventions under investigation include: Methotrexate (DRUG), Prednisone or Prednisolone (DRUG).

Who is sponsoring clinical trial NCT03593759?

This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03593759 being conducted?

This trial has 20 study locations across Connecticut, Massachusetts, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.